The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Jan 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how certain sounds, specifically live ocean music, can affect the breathing stability and brain oxygen levels in premature infants. The trial involves babies born between 24 and 37 weeks of gestation at Mount Sinai Hospital. To participate, infants need to be in stable condition and appropriate for music therapy, meaning they can safely handle the sounds used in the study. Unfortunately, infants who are not expected to survive for at least 24 hours, those with very low birth weight, or suspected genetic or hearing disorders cannot participate.

During the trial, eligible infants will be randomly assigned to two groups: one will listen to the ocean sounds, while the other will experience silence. Each baby will have three sessions per week for two weeks, where they will listen to both the ocean sounds and silence on the same day, in random order. The researchers will monitor how these sounds impact the infants' breathing, heart rate, and oxygen levels, while also ensuring the noise level remains safe. Parents and nurses will continue their usual care routines during the study, creating a familiar environment for the babies. Overall, this trial aims to understand if these soothing sounds can help improve the health and well-being of premature infants in the NICU.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Newborns born at 24-37 weeks' gestation at Mount Sinai hospital
• • Newborn is considered appropriate for clinically indicated music therapy
• Exclusion Criteria:
• • Infant not expected to survive 24 hours from the time of study entry (To be assessed by a member of the NICU Faculty other than the PI)
• • Infant of uncertain viability (gestation \<23 weeks, birth weight \<500 grams)
• • Known or suspected genetic disorder (e.g., Trisomy 21)
• • Identified hearing disorder